About the role
Our client is a Class III medical device start-up hiring an R&D Catheter Engineer on a six-month contract-to-hire basis. The role is open to entry-level engineers as well as candidates with 2-3+ years of medical device R&D experience.
You’ll support the research and development of catheter-based devices, from early concepts through design verification. That includes rapid prototyping and 3D printing, mechanical design in SolidWorks, and hands-on testing. Catheter development typically involves processes such as extrusion, braiding or coiling, reflow, and bonding. Performance is usually assessed through tests like tensile, torque, kink, burst, and trackability.
Testing and documentation are central to the role. You’ll develop test methods, carry out testing, complete test method validations (TMVs), and support design verification testing (DVT), using statistical analysis tools such as MATLAB or Minitab to interpret results. You’ll also create and update design history files (DHFs).
As a Class III device company, our client works within a highly regulated quality environment. Work is carried out under ISO 13485 and FDA design control requirements, and Class III devices typically go through the premarket approval (PMA) pathway, so careful, well-documented engineering is essential.
Main responsibilities
- Support R&D of catheter-based Class III medical devices
- Design components and assemblies using SolidWorks
- Build prototypes using rapid prototyping and 3D printing
- Develop test methods, carry out testing, and complete TMVs
- Support design verification testing (DVT)
- Analyze test data using statistical tools such as MATLAB or Minitab
- Create and update DHFs
- Work within an ISO 13485 quality management system
Requirements
- B.S. in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a similar discipline
- SolidWorks experience
- Knowledge of ISO 13485
- Rapid prototyping and 3D printing experience
- Statistical analysis experience (MATLAB, Minitab, or similar)
- Experience with test method development, testing, and TMVs
- Experience creating and/or updating DHFs
- DVT experience
Nice to have:
- Catheter experience or prior medical device R&D experience
- Japanese language skills
The offer
- Six-month contract, with conversion to permanent
- Open to entry-level candidates and those with 2-3+ years of medical device R&D experience
- Hands-on R&D work on Class III medical devices at a start-up
This role suits an engineer who wants to work on catheter-based Class III devices from prototype through verification, whether you’re starting out or have a few years of medical device R&D behind you. If that sounds like you, apply below.